2.7mm Cortical Screw, Self-Tapping, (Star Head), 10mm length

Primary DI
08903993538715
Brand
2.7mm Cortical Screw, Self-Tapping, (Star Head), 10mm length
Company
Auxein Medical Private Limited
Model
Ti-1242.10S
Device description
2.7mm Cortical Screw, Self-Tapping, (Star Head), 10mm length
Published
2022-04-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HRCSterilizer, Soft-Lens, Thermal, Battery-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRCSterilizer, Soft-Lens, Thermal, Battery-PoweredOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211324000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K2113240002.4mm Distal Radius SystemAuxein Medical Private Limited2022-03-14HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08903993538715PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08903993538715089039935387158903993538715

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw, non-bioabsorbable, sterileA small, sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). There are a number of kinds available: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A "lag screw" can be any of these used to obtain compression across bone fragments.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+91 9910643638info@auxein.com

Regulatory Flags#

DUNS number
872194615
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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089039935385312.4 mm Wise lock Screw, Self tapping, Star Head, 26mm lengthAuxein Medical Private LimitedHRC2022-04-28
089039935387222.7mm Cortical Screw, Self-Tapping, (Star Head), 12mm lengthAuxein Medical Private LimitedHRC2022-04-28
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